Roche Enters MASH Market with Strategic Acquisition
Roche has officially entered the metabolic dysfunction-related steatohepatitis (MASH) space by acquiring 89bio and its promising phase-3 candidate for fatty liver disease.
Details of the Acquired Candidate
Pegozafermin, an FGF21 analog, is currently in late-stage trials for MASH in patients with moderate to severe fibrosis and liver cirrhosis. 89bio anticipates a phase 3 trial readout in the first half of 2027, but the existing data was compelling enough for Roche to bring pegozafermin into its pipeline.
Financial Terms of the Deal
The Swiss pharmaceutical giant is acquiring the San Francisco-based biotech in an all-cash deal at a 79% premium, valued at $14.50 per share. Additionally, 89bio stockholders could receive a contingent value right of up to $6 per share based on specific commercial milestones. These milestones are tied to the initial sale of pegozafermin in F4 MASH cirrhosis patients before March 31, 2030. The total equity value of the deal could reach approximately $3.5 billion, as stated by Roche in a September 18 release. The acquisition is expected to close in the fourth quarter, integrating 89bio employees into Roche’s pharmaceuticals department.
Strengthening Roche’s Portfolio
‘This acquisition also enhances our portfolio in the cardiovascular, renal, and metabolic disease and provides potential to combine with the already existing programmes in our pipeline,’ said Roche Group CEO Thomas Schinecker in the release. He added, ‘pegozafermin has a promising future to emerge as a transformative therapy in MASH, which is one of the most common comorbidities of obesity, and the ability to satisfy individual patient needs related to this complex illness.’
The Growing MASH Treatment Landscape
Pegozafermin gained significant interest after 89bio published positive results from a phase 2b clinical trial in 2023, showing the FGF21 analog reduced liver scarring in MASH patients. This follows a similar path as Akero Therapeutics, which demonstrated proof-of-concept for FGF21 analogs in MASH treatment in 2022.
The MASH space has become increasingly active. In 2024, the FDA approved Rezdiffra from Madrigal Pharmaceuticals, the first MASH drug in the U.S. market. More recently, Novo Nordisk’s blockbuster weight loss drug, Wegovy, was approved to treat fatty liver disease. Despite Madrigal’s first-mover advantage, analysts from Evercore ISI noted, ‘this is a big market with lots of room for players and treatment options.’
Future Outlook
The FDA is also considering the adoption of noninvasive liver measures as surrogate endpoints for some MASH patients, a move that could significantly accelerate drug development in this competitive field.
Outlook and Forward Plans
As Roche integrates 89bio into its Pharmaceuticals division, the company will need to manage technical, clinical, and regulatory risks. The CVR payments are contingent on commercial success and regulatory approval, so some upside remains speculative. Roche must also navigate competition from other pharma players advancing MASH and metabolic therapeutics.
If pegozafermin meets its endpoints and gains regulatory approval, it could be positioned as a transformative standard of care in the MASH space. With its anti-fibrotic and anti-inflammatory actions, Roche could seek combinations of pegozafermin with agents targeting insulin resistance, lipid metabolism, or other pathways — thereby maximizing patient benefit across metabolic and liver comorbidities.
In parallel, Roche may lean into real-world evidence (RWE) and post-market data from early users to further define patient subgroups, optimize dosing, and support label expansions. Over time, Roche’s entry into MASH counters prior criticism of absence in the obesity-metabolic disease arena, and positions the company as a more comprehensive player across metabolic, renal, cardiovascular, and hepatic domains.
Roche’s Broader Metabolic Vision
Roche’s move into the MASH market aligns with its broader ambition to expand leadership in metabolic and liver-related disorders. The company has historically focused on oncology, neuroscience, and immunology, but the growing global burden of obesity and metabolic dysfunction has created an urgent need for pharmaceutical innovation. By acquiring 89bio, Roche positions itself at the intersection of metabolic and hepatic medicine, bridging its cardiovascular and renal expertise with a new liver-focused therapeutic strategy.
